Advice

Summary

Summary

  • The technologies described in this briefing are the eazyplex SuperBug kits (complete A, complete B and CRE). They are used with the Genie II platform to detect carbapenemase-producing organisms (CPOs) and selected extended-spectrum beta-lactamase (ESBL) genes in rectal swab samples.

  • The innovative aspects are that they are molecular diagnostic tests to detect bacterial DNA in up to 30 minutes, and can identify major types of carbapenemases.

  • The intended place in therapy would be instead of the first stage culture-based tests currently used to detect CPOs, but antimicrobial-resistance testing would still be needed for CPO-positive samples.

  • The key points from the evidence summarised in this briefing are from 4 studies (1 comparative diagnostic performance study, 2 diagnostic performance studies and 1 proof-of-concept study) including a total of 721 samples. One study reported that the sensitivity and specificity of the SuperBug complete A were 95.5% and 100% respectively. One study reported 100% agreement between the eazyplex SuperBug CRE system and laboratory sequencing results for clinical isolates. One study reported that the sensitivity and specificity of the SuperBug CRE test were 100% and 97.9% respectively, for the detection of the ESBL genes in urine samples.

  • Key uncertainties around the evidence are that none of the studies evaluated the kits as they are intended to be used in clinical practice, because they did not test rectal swab samples. It is also limited to data generated from diagnostic performance studies conducted in vitro with no data on clinical outcomes for patients.

  • The cost of the eazyplex kits is £755 for 24 single-use tests and the Genie II system costs £9,000 (exclusive of VAT). These are more expensive than standard culture-based tests (about £7 per test) and would therefore carry additional acquisition costs.

  • NICE has also published a medtech innovation briefing on the Xpert Carba-R test to identify people carrying CPOs.